System and method for performing percutaneous spinal interbody fusion

ABSTRACT

A method of performing percutaneous interbody spinal fusion on adjacent vertebrae in a patient including the steps of: creating a percutaneous access opening on the patient, using indirect visualization to establish a surgical path through the access opening, creating a cavity in a disc space between the adjacent vertebra, without retraction, inserting an expandable implant into the cavity, the implant configured to fit through the access opening into the cavity, and expanding the implant within the cavity.

PRIORITY

The present application is a continuation of U.S. patent applicationSer. No. 15/207,430, filed Jul. 11, 2016, now U.S. Pat. No. 9,913,725,which is a continuation of U.S. patent application Ser. No. 14/563,987,filed Dec. 8, 2014, now U.S. Pat. No. 9,387,088, which is a continuationof U.S. patent application Ser. No. 12/650,889, filed Dec. 31, 2009, nowU.S. Pat. No. 8,906,094, which claims the benefit of U.S. ProvisionalApplication No. 61/141985, filed Dec. 31, 2008. Each of the foregoingapplications is herein incorporated by reference in their entirety.

FIELD

The present invention relates generally to a system and method forperforming a spinal interbody fusion. In particular, the presentinvention relates to a system and method for performing percutaneousspinal interbody fusion.

BACKGROUND

It is recognized that the spinal disc consists of three parts: first,the nucleus, a central portion that is a compression-resisting cushion;second, the annulus, a peripheral rim portion that is atension-resisting hoop; and third, the end plates, the superior andinferior borders of the disc, consisting of the upper and lower surfacesof the vertebral body bones adjacent to the disc. Many studies haveconcluded that mechanical back pain is the most common and costlymusculoskeletal condition affecting middle-aged humans in modernsocieties. Mechanical back pain may be caused by several factors, butoverwhelming evidence suggests that degeneration of the spinalintervertebral disc, such as may be caused by Degenerative Disc Disease(DDD) is the most common condition causing back pain symptoms.

Many devices have been invented for the purpose of stabilizing and/orreplacing parts of the disc in an effort to ease the pain associatedwith degenerative disc disease. Previous devices designed to treat DDDfall generally into the following four classes:

The first class includes rigid, three-dimensional geometric soliddevices, either impervious or porous, that function as support struts.When these devices are placed between adjacent vertebral bodies theyallow, and in some cases encourage bone to grow through and/or aroundthe device to cause a bony fusion between two adjacent vertebral bodies.Rigid implants fabricated from metal, ceramic, or hard plastics sufferfrom several disadvantages such as: the need to create large surgicalexposures disruptive to muscle and soft tissue, the need for largedestabilizing entrance holes through the annulus of the disc, and thepresence of large volumes of non-biologic material that reduce bonegraft surface contact at the end plate.

The second class involves the use of semi-rigid artificial joints thatallow motion in one or more planes. Examples include: U.S. Pat. No.4,759,769 to Kostuik; U.S. Pat. No. 6,039,763 to Shelokov, andcommercially available examples such as the Link device or the ChariteIntervertebral Disc Endoprosthesis. These artificial joints have severaldisadvantages, including: the artificial joints are technicallychallenging to the surgeon in that proper placement of the device can bequite difficult, placement of the device requires large anteriorexposures and re-operation procedures, if needed, are dangerous(life-threatening) due to anterior scarring and inability to use anothersurgical approach.

The third class is directed to non-rigid cushions designed to replacethe nucleus of the disc. Examples of artificial discs are described inU.S. Pat. No. 4,904,260 to Ray, U.S. Pat. No. 4,772,287 to Ray and U.S.Pat. No. 5,192,326 to Bao. These devices are prone to wear andsubsidence and as such pose a risk to the surrounding anatomy when theybecome dislocated out of the disc space.

Finally, the fourth class is the relatively new area of initiallyflexible, deployable containers that become rigid when injected withmaterials that can support loads. Examples include U.S. Pat. Nos.5,571,189, 5,549,679 and 6,712,853 to Kuslich, the contents of which areincorporated in the entirety herein, each of which describe deployable,porous containers, useful in stabilizing a deteriorating spinal disc.The container is placed into a reamed out intervertebral space and isexpanded by the introduction of graft material which may be tightlycompacted within the container.

Like many other areas of surgery, spine surgery has become less invasiveas smaller, more precise technology develops. Many minimally invasiveintervertebral fusion devices exist, such as those disclosed in U.S.Pat. Nos. 5,571,189 and 5,549,679 and the commercially available XLIF®procedure by NuVasive. However, all minimally invasive fusion devicesstill require a surgical access opening that is as large as the deviceto be implanted. Generally speaking, the access aperture in minimallyinvasive procedures is at least 15-30 mm in diameter. Also, becauseminimally invasive procedures require direct visualization, the surgeonmay need to cut bone and must significantly retract soft tissues and thenerve root, potentially causing nerve root injury or persistentpost-operative pain.

By contrast, percutaneous surgery is done using x-ray visualization andimage guidance and as such does not require resection of bony or softtissue for direct visualization of the disc. Further, the incision isgenerally in the range of about 10 mm, much smaller than the accessaperture in MIS procedures. Thus, percutaneous surgery results in adramatic reduction in morbidity rates and more rapid recovery, both ofwhich leading to significantly shorter hospitalization times.

U.S. Pat. Nos. 6,558,383 and 7,087,058 to Cragg describe a percutaneousmethod of fusing the lumbo-sacral region of the spine from an axialapproach. The method and system described by Cragg are limited to fusingeither the L5-S1 or the L4-L5-S1 motion segments using a rigid deviceand are further limited to an axial approach. Further, although Craggdescribes the method as being percutaneous, the method still requires anaccess opening of at least 22 mm to accommodate the implant. The largera surgical exposure is, the greater the likelihood of attendant bleedingand injury to local muscular, ligamentous, vascular and nervous tissuesand in the lumbar region, the bowels may also be damaged.

Any device that would more easily, and/or more effectively, and/or moresafely treat degenerative disc disease would be useful in the managementof hundreds of thousands of suffering individuals. The current inventionis an improvement to current systems and methods of performing interbodyfusion because it enables surgeons to finally perform a truepercutaneous interbody fusion at all levels of the spine.

The entire content of each and all patents, patent applications,articles and additional references, mentioned herein, are respectivelyincorporated herein by reference.

The art described in this section is not intended to constitute anadmission that any patent, publication or other information referred toherein is “prior art” with respect to this invention, unlessspecifically designated as such. In addition, this section should not beconstrued to mean that a search has been made or that no other pertinentinformation as defined in 37 C.F.R. § 1.56(a) exists.

SUMMARY

The system and method of the present invention accomplish truepercutaneous interbody fusion. Unlike currently available systems, thepresent invention utilizes indirect x-ray visualization. According toone embodiment of the present invention, a posterolateral approach isused to access the spine. Using the percutaneous system and method ofthe present invention requires no nerve root, aorta, vena cava or duraretraction, there is no need to flip the patient over and there is veryminimal bony resection. Thus, the percutaneous system and method of thepresent invention results in significantly less soft tissue damage,blood loss, post-operative pain, scar tissue and vascular injury thanminimally invasive interbody fusion.

According to another aspect of the percutaneous system and method of thepresent invention, indirect, image guided visualization is used toaccomplish interbody fusion at any location in the entire lumbar spine.

In an embodiment of the percutaneous system and method of the presentinvention the deployable container may conform to the size and shape ofthe endplates. According to one aspect, the deployable container may beinserted in a collapsed state through a percutaneous incision and filledwith fill material to a size and shape significantly larger than thepercutaneous access opening. This method of filling allows fordistraction of the interbody space such that as the container is filledwith fill material the motion segment may be lifted. In turn, this discspace distraction leads to indirect decompression of the nerve rootspassing through the foramen at the affected level, helping to relievethe radicular leg pain commonly associated with degenerative discdisease.

According to another embodiment of the percutaneous system and method ofthe present invention, a neural stimulating component may be utilized toensure a safe access trajectory for introduction of subsequentinstruments to the surgical site. In one aspect, such neural stimulatingcomponent may have a diameter in the range of about 2 mm.

In one embodiment the present invention may be a method of performingpercutaneous interbody spinal fusion on adjacent vertebrae of a patientthat may include the steps of: creating an access opening on thepatient, the access opening being less than 10 mm wide, using indirectvisualization: establishing a surgical path through the access openingvia neural monitoring, creating a cavity in a disc space of the adjacentvertebrae, evaluating the created cavity, inserting a container sizedand configured to fit through the less than 10 mm access opening intothe cavity and filling the container with fill material. According toone aspect of the present invention the method may further include thestep of sequential dilation.

According to another aspect of the present invention, the method mayfurther include the step of filling the container sufficiently todistract adjacent vertebrae.

In another embodiment, the present invention may be a system forperforming percutaneous interbody spinal fusion on adjacent vertebrae ofa patient that may include: imaging equipment adapted to provideindirect visualization of the patient, a neural stimulating componentconfigured to establish a surgical path through a less than 10 mm accessopening, at least one cavity creation tool, a discectomy evaluationdevice, a container sized and configured to fit through a less than 10mm access opening and fill material adapted for filling the container.

According to one aspect of the present invention, the system may furtherinclude sequential dilators.

In yet another embodiment, the present invention may be a kit forperforming percutaneous interbody spinal fusion on adjacent vertebrae ofa patient which may include: imaging equipment adapted to provideindirect visualization of the patient, a neural stimulating componentconfigured to establish a surgical path through a less than 10 mm accessopening, at least one cavity creation tool, a discectomy evaluationdevice, a container sized and configured to fit through a less than 10mm access opening, fill material adapted for filling the container andinstructions for using the kit.

According to one aspect of the present invention, the kit may furtherinclude sequential dilators.

In another embodiment, the present invention may be a method forperforming percutaneous interbody spinal fusion on adjacent vertebrae ofa patient including the steps of: providing: imaging equipment adaptedto provide indirect visualization of the patient, a neural stimulatingcomponent configured to establish a surgical path through a less than 10mm access opening, at least one cavity creation tool, a discectomyevaluation device, a container sized and configured to fit through aless than 10 mm access opening, fill material adapted for filling thecontainer and providing instructions for use.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example percutaneous skin incision.

FIG. 2 depicts an example neural stimulating component inserted into apatient's anatomy.

FIG. 3 depicts one embodiment of a first dilator.

FIG. 4 depicts an embodiment of a second dilator.

FIG. 5 illustrates an embodiment of a force dissipation apparatus.

FIG. 6 illustrates an embodiment of a screw placed through an embodimentof an access portal.

FIG. 7 depicts an embodiment of a shaper in a collapsed position.

FIG. 8 depicts an embodiment of a shaper in an expanded position.

FIG. 9 illustrates an embodiment of a reamed out intervertebral cavityafter the use of a shaper.

FIG. 10 depicts an embodiment of a tissue removal tool.

FIG. 11 illustrates a bilateral embodiment of the present inventionwherein a second tissue removal tool is used.

FIG. 12 depicts an embodiment of a cleared intervertebral cavity.

FIG. 13 illustrates an embodiment of a discectomy evaluation device in acollapsed state.

FIG. 14 illustrates an embodiment of a discectomy evaluation device inan inflated state.

FIG. 15 depicts the placement of sentinel graft.

FIG. 16 illustrates an embodiment of a container in a collapsed stateaccording to the present invention.

FIG. 17 illustrates an embodiment of a container according to thepresent invention in a partially filled state.

FIG. 18 illustrates an embodiment of a container according to thepresent invention in a filled state.

FIG. 19 illustrated an embodiment an intervertebral cavity aftercontainer and sentinel graft placement.

FIG. 20 illustrates screw placement according to an embodiment of thepresent invention.

DETAILED DESCRIPTION

The present invention includes a comprehensive system and method forperforming a true percutaneous interbody fusion. Generally, as shown inFIG. 1, the percutaneous incision is a small stab wound, no more than 10mm in length. The system may include: a neural stimulating component, adiscectomy evaluating device, disc removal/cavity creation tool(s), adeployable container and fill material. The steps of the method ofpresent invention may include: using indirect visualization,percutaneously placing a neural stimulating component; preparing afusion bed by creating a cavity; evaluating the cavity; inserting acontainer and filling the container with fill material.

According to the present invention, percutaneous interbody fusion isperformed under indirect visualization using x-ray or other imagingvisualization without any direct visualization. Because neural tissuecannot be seen on x-ray, there is a need for active neural monitoring toensure there is no injury to the surrounding nerves during theprocedure. There are two types of monitoring that are generally used inspine surgery: Electromyography (EMG) and Somatosenory Evoked Potential(SEP). When using neural monitoring in the spine, the surgeon isevaluating nerve potential, that is, its ability to react, and checkingfor evoked responses. An instrument, such as a neural stimulatingcomponent, is used to mechanically manipulate or electrically stimulatethe nerve in order to evoke a response. The main difference between EMGand SEP is that EMG looks at muscle responses and therefore is used fortracking nerve root response and SEP is used for dorsal columnmonitoring or spinal cord responses.

The present invention includes methods and devices for performing neuralmonitoring, i.e. nerve root mapping and also implant stimulation for themetallic stabilizing implants such as pedicle screws. In one embodiment,the neural stimulating component may be a fully insulated wire shaftwith an exposed blunt distal end portion. The insulated wire shaft mayinclude a detachable handle and shaft that is sized to fit through a 3mm exchange tube. In another embodiment, the neural stimulatingcomponent may be a fully insulated blunt shaft having an exposed distalend and detachable handle that is further sheathed with a cannula. In analternate embodiment, the neural stimulating component may be aninsulated guide pin with a fully shielded blunt tip having an exposeddistal end and detachable handle that will accept a series of interimdilators that can be impacted, with a small cap, into the disc prior toan access portal. In yet another embodiment, any of the aforementionedneural stimulating components may include a sharp tip such that the tipcould be used to pierce the disc following docking.

In a preferred embodiment, as shown in FIG. 2, the neural stimulatingcomponent may be a fully insulated metal shaft with an affixed handlehaving a blunt tip with an exposed distal end. The neural stimulatingcomponent may have an exchange tube placed over the neural stimulatingcomponent. The exchange tube provides rigidity for neural stimulatingcomponent guidance through dense tissues and facilitates placement ofsharps safely down to the spinal surface following identification of asafe trajectory by placement of the insulated probe. Inclusion of anexchange tube allows placement of sharps safely past the nerve root. Inother words, inclusion of an exchange tube allows the delivery of asharp cannulated spinal system pin or needle to the surface of the spineor into the spine. Such exchange tubes may be made of plastic or metal.

The exchange tube provides added rigidity to the neural stimulatingcomponent for ease of insertion. In the case of a metal exchange tube,the exchange tube is radiopaque for enhanced fluoroscopic monitoring.The exchange tube is shorter than the neural stimulating component toprevent electrical current from shunting to the tube rather than thebeing transferred to the tissue surrounding the tip. In use, the neuralstimulating component is inserted with the exchange tube over the neuralstimulating component tip but pulled back proximally against the neuralstimulating component handle. The nerve root is safely traversed asconfirmed by neuromonitoring, and the neural stimulating component tipmay be seated against the outer surface of the annulus. The exchangetube may then be advanced over the neural stimulating component anddocked at the annulus surface and the neural stimulating component maybe removed, a standard guide pin may then be placed and the exchangetube may be removed. This embodiment and procedure permits safenavigation and placement of a cannula into the intervertebral disc forany subsequent type of intervertebral disc intervention or treatment.

Another embodiment may include a neural stimulating component that maybe an insulated guide pin having a lead attached to its distal end.According to this embodiment, the monitoring technique may includepassing the guide pin into the patient while the guide pin iselectrified. If no response is evoked, the pin may then be tapped intothe disc.

Any embodiment of the neural stimulating component may be pre-packedsterile and disposable for surgeon convenience.

Features of any embodiment of the neural stimulating component mayinclude: a blunt tip to prevent the potential for nerve damage due topuncture and to ensure uniform electrical flow out of the tip; thecomponent may be insulated to within ½ to 1 mm of the tip to concentratestimulus location and to prevent electrical shunting to an exchangetube; an exposure in the range of about 0.5 mm at the neural stimulatingcomponent tip enables targeted delivery of the current to map neuralstructures and define a clear trajectory during percutaneous pin orneedle placement in spinal procedures; the neural stimulating componentcan be used with most standard monitoring systems.

In another embodiment, the neural stimulating component may have aconcentric bipolar design. In contrast to a monopolar design, thebipolar design includes an electrical return that is integrated into thecomponent itself rather than being a separate pin that is placed in thepatient as is done with monopolar designs.

The neural stimulating component may be in the range of about 150 to 200mm in length and 1 to 2 mm in diameter. The exchange tube is in therange of about 125 to 175 mm in length with an inner diameter of about2.5 mm and a very thin wall. In the event the exchange tube is comprisedof plastic, the exchange tube length may equal the length of the neuralstimulating component.

The present invention may also include a series of one or more softtissue dilators for safe insertion of a larger working cannula toaccommodate other surgical instruments. In order to mitigate anypotential nerve root irritation a set of incremental dilators isenvisioned. In one embodiment, the system and method of the presentinvention may include placing a guide pin in the range of about 2.5 mmthrough the exchange tube safely placed by use of a neural stimulatingcomponent as described above, then placing a dilator in the range ofabout 4 mm over the pin which opens the disc space and then a dilator inthe range of about 6.5 mm may be placed over the about 4 mm dilator.

The preferred embodiment of each dilator includes a tapered tip for easeof insertion and for gentle deflection of the nerve roots or other softtissue structures which the dilator passes. Each dilator size will havea corresponding impactor device in the form of a cap which passes freelyover the previously passed pin or dilator to prevent inadvertentadvancement, but which permits advancement of the dilator by impactingwith a mallet if needed. The abovementioned sizes are for example onlyand one of ordinary skill in the art will recognize that variations inthe sizes and the number of dilators used are within the scope of thedisclosure.

The intent of the incremental dilators is to gradually increase thediameter from a guide pin diameter, typically in the range of about 1 to2.5 mm, up to the desired access portal diameter, typically in the rangeof about 5.5 to 7.5 mm. The dilation step of the present inventionincludes penetrating the surface of the annulus to enter the disc spacewith the dilators and not merely placing the dilators on the surface ofthe spine.

The incremental dilation is gentler than conventional dilationtechniques. By moving the superior vertebra in relation to the inferiorvertebra via insertion of a first dilator, the nerve will move slightlyas well and increase the peri-neural volume such that the next largerdilator can be more safely placed. By penetrating the disc surface withthe dilators, any neural structures that are in close proximity to thedilator will be deflected out of the way until they are at the majordiameter of the part. Then, when the next larger dilator is passed overthe previously placed smaller dilator, the minor diameter of the largerdilator will be able to pass by the root and deflect the root furtherout of the way until the root is now at the major diameter of thatlarger dilator.

This incremental dilation with insertion of the tapered dilator tip intothe disc space and the corresponding gradual deflection of the nerveroot to the dilator's major diameter varies greatly from other tissuedilators that dock against the spine surface. With docking types ofsystems, the first dilator tip contacts the surface of the annulus butdoes not penetrate the intervertebral disc space. The next largerdilator then comes down to the disc surface and as the tapered tip ofthe larger dilator passes the tapered tip on the smaller dilator a gapis formed. This gap creates the potential for a nerve to becomeentrapped against the surface of the spine below the tip of the largerdilator.

The dilators of the present invention may be radiopaque, radiolucent orat least partially lucent. The benefit of the radiolucency is that itwill make the impaction depth of an access portal seating over thedilator easier to view with an x-ray. This impaction depth is criticalto ensuring good container size selection and optimal positioning. Thedilators may be made of a plastic, aluminum or any other suitablematerials and may be color coded for size.

The system of the present invention may also include a shaper to cut outthe intervertebral space to create a cavity and prepare a fusion bed ofbleeding bone at the endplates to facilitate new bone growth for fusionto occur. Any shaper that can be introduced percutaneously may be used.In some embodiments a tissue removal device, such as is disclosed inco-pending application Ser. No. 12/056,025 the disclosure of which isincorporated herein in its entirety, may also be used to evacuate theintervertebral cavity. In a preferred embodiment, a shaper as isdisclosed in co-pending application Ser. No. 10/842,057, the disclosureof which is incorporated herein in its entirety, may be used.

Thorough preparation of the intervertebral disc space is also enhancedby the use of other tools adapted for percutaneous use, such ascurettes, pituitary rongeurs, other surgical graspers, andsuction/irrigation equipment. According to an embodiment the cavitycreated is larger than the access opening. In one embodiment of thepresent invention, an articulating curette may be used to create acavity in a single plane, that is the width of the cavity may be createdindependent of the height of the cavity. The articulating motion alsoallows for the creation of a cavity off to one side of the disc space,if desired.

In one embodiment of the present invention, the shaping/cutting toolsmaybe set to different lengths and angles to determine the volume ofdisc material removed.

The system and method of the present invention may also include adiscectomy evaluation component comprising a cannula having a bladderportion at its distal end. The discectomy evaluation device may be usedto determine the thoroughness of the discectomy. In an embodiment, thebladder of the discectomy evaluation device may be compliant so that itwill conform to the created cavity rather than cause the creation of acavity. In one aspect, the bladder portion of the discectomy evaluatingdevice may be comprised of latex, silicone, polyurethane or any othermaterial that is compliant at low pressures. In an embodiment of thepresent invention, the cannula of the discectomy evaluating device maybe comprised of PEBAX. In another embodiment, the discectomy evaluatingdevice may be non-compliant, such that upon filling, the device willgenerate lift and terminate at a filled size that corresponds to thedesired container size.

The discectomy evaluating device may be in the range of about 4 to 6 mmin diameter in its collapsed state for insertion through a cannula, andin the range of about 2.5 to 20 cc when inflated. In one embodiment, theassembly of the discectomy evaluation device may include smallradiopaque marker bands for x-ray visualization of the position of thedevice upon its initial insertion.

The discectomy evaluating device may be placed on a radiopaque cannulaso that it may be seen on x-ray upon insertion. In one embodiment, thediscectomy evaluating device may be placed in a radiopaque protectiveinsertion sheath to protect the bladder while remaining lucent.

In a preferred embodiment, the discectomy evaluating device may beplaced on an internal cannula of sufficient diameter to allow thediscectomy evaluating component to be inflated using low pressure with asimple syringe. With a smaller diameter and greater length, the cannulawill require greater inflation and deflation force. Using high pressurecould cause the undesirable extrusion of unretrieved disc nucleusmaterial.

The discectomy evaluation device cannula dimensions may range from about1 mm to 3 mm diameter and of sufficient length to pass through an accessportal and enable the operator's hands to be outside of the x-ray beam.The bladder of the discectomy evaluation device may include an invertedtip which allows distal expansion past the cannula so that the entirecannula need not be inserted into the disc space.

In order to see the location and relative volume of the cavity that hasbeen created in the disc space, the physician may inflate the discectomyevaluation device with radio-opaque dye. This iterative step may help toidentify incomplete removal of disc fragments and to guide the surgeonin further disc removal. In another embodiment the discectomy evaluationdevice material may be radio-opaque, or may include radio-opaque markersand then the discectomy evaluation component may be inflated withsaline.

The discectomy evaluation device cannula may also include a valve toallow the surgeon to fill the discectomy evaluation component, close thevalve to maintain the filled volume, and then step out of the radiationzone as the image is taken. In another embodiment, the discectomyevaluation component may identify annular defects and endplate fissuresas it conforms to the cavity.

The system of the present invention may also include a porous container.The container is pliable and malleable before its interior space isfilled with fill material. The material of the container may beconfigured to take on the shape of the cavity in which the container isplaced. The container may be sized, in the range from about 1 to about 4cm in diameter, being roughly spherical or cylindrical in shape,although other ellipsoidal shapes and other geometric shapes may beused. In an initial collapsed condition, the container may be insertedinto the created cavity through a very small opening in the range fromabout 3 mm to about 10 mm in diameter.

The container may be constructed from material that is woven, knitted,braided or form-molded to a density that will allow ingress and egressof fluids and solutions and will allow the ingrowth and through-growthof blood vessels and fibrous tissue and bony trabeculae to promotefusion, but the porosity may be tight enough to retain small particlesof enclosed material, such as ground up bone graft, or bone graftsubstitute such as hydroxyapatite or other osteoconductive biocompatiblematerials known to promote bone formation. The container may include aplurality of pores. Generally, the pores may have a diameter of about0.25 mm or less to about 5.0 mm. The size is selected to allow tissueingrowth and bony fusion while containing the material packed into thecontainer. If bone cement or other material is used which will notexperience bone ingrowth, the pores may be much tighter to preventegress of the media from within the container out into the cavity. Thisprevents leakage that could impinge upon nerves, blood vessels or thelike if the fill material is allowed to exit the bone. When thecontainer is fully filled with fill material, the container will form aself-retaining shape which conforms to and substantially fills thecavity.

The size and density of the pores determine the ease or difficulty withwhich materials may pass through the container. For instance, very smallpores (<0.5 mm) would prohibit passage of all but the smallest particlesand liquids. The pore size and density could be controlled in themanufacturing process, such that the final product would be matched tothe needs of the surgeon. For example, if methylmethacrylate bone cementwere to be used, the pore size would need to be very small, such asabout less than 0.5 mm to about 1.0 mm, whereas, when bone graft orbiocompatible ceramic granules are used, pore sizes ranging from about1.0 mm to about 5.0 mm or more may be allowed. The pores could bedifferentially placed such that fill material may be preferentiallyextruded from certain zones of the container.

The container need not be woven and may be molded or otherwise formed asis known in the art. The preferred material may provide the ability totailor bioabsorbance rates, for example, such as is disclosed inco-pending application Ser. No. 11/901,237, the disclosure of which isincorporated by reference herein in its entirety. Any suture-typematerial used medically may be used to form the container. The bag maybe formed of plastic or even metal. In at least one embodiment,container may be formed using a combination of resorbable and/ornonresorbable thread. The container may be partially or totallyabsorbable, metal, plastic, woven, solid, film, an extruded balloon orany other biocompatible material.

The container may be radio-opaque or include markings for x-rayvisualization during insertion and filling. In an embodiment, suchmarking may include pad printing or other marking method with anybiocompatible ink. According to one aspect, such medical gradebiocompatible radiopaque ink may be loaded with tantalum powder. Markingmay be placed at any desired location. In a preferred embodiment,markings may be placed at the proximal and distal ends of the container.

The fill material used in the present invention may include one or moreof the following, or any other biocompatible material judged to have thedesired physiologic response: Demineralized bone material, morselizedbone graft, cortical, cancellous, or cortico-cancellous, includingautograft, allograft, or xenograft; Any bone graft substitute orcombination of bone graft substitutes, or combinations of bone graft andbone graft substitutes, or bone inducing substances, including but notlimited to: calcium phosphates, calcium sulfates, calcium carbonates,hydroxyapatite, bone morphogenic proteins, calcified and/or decalcifiedbone derivatives; and Bone cements, such as injectable ceramic andpolymethylmethacrylate bone cements.

One method of performing a percutaneous interbody fusion according tothe present invention may include a combination of the following steps:

Positioning and neural monitoring to determine trajectory for surgicalaccess which may include: Using anterior-posterior imaging, the surgeonmay orient the guide pin on the skin, such that the tip is aligned witha line encompassing the lateral margins of the ipsilateral pedicles andcentered on the disc. The surgeon may then mark the spot with a skinmarker. Next the surgeon may re-orient the guide pin such that the tipis in a like spot on the contralateral side (lateral margin of thepedicles centered on the disc) and mark. A line may then be drawn thatconnects the dots and extends well lateral of each mark. This lineindicates the implantation trajectory.

Next the surgeon may measure the width of the spine, the distancebetween the dots, and transpose this dimension laterally along the linein both directions from the lateral boarders of the spine. Theselocations may then be marked. These second set of marks indicate theapproximate incision locations. The distance the incision is made frommidline is largely dependent on patient size and the level of thepathology. The larger the patient and/or the lower the level, thefurther from midline the incision may need to be. (ex. at L4-5 in aheavy patient the incision location may need to be an additional 50%further lateral). The skin may then be incised at one of these markedincision locations.

The initial trajectory may be identified through the use of active EMGneural stimulation. To prepare the equipment for probing the exchangetube may be placed over the neural stimulating component until theexchange tube contacts the handle. A return lead needle may then beplaced through the patient's skin and into the posterior musculatureapproximately 5-8 cm, or the desired depth from the incision site. TheEMG machine may then be set to deliver approximately 10 mA, or thedesired amperage to the neural stimulating component.

The surgeon may use image guidance to insert and advance the neuralstimulating component as desired while targeting the superior lateralwall of the pedicle immediately inferior to the target disc. This willprevent inadvertent transgression of the foramen and canal and aid inguiding the tip of the neural stimulating component to a position medialto the exiting root. As the neural stimulating component is advanced, asis shown in FIG. 2, the electrified tip will be seeking to evoke aneural response. If at any time the technician detects a response, thephysician will cease advancement and may slightly retract the neuralstimulating component because the response is an indication that thenerve root is in, or near, the current trajectory. At this point one oftwo actions may be taken: either the power is titrated down to thedesired amperage or the neural stimulating component is redirected to aslightly more inferior and/or medial orientation. The physician may thencommence re-advancement of the neural stimulating component.

Initial bony contact should be with the pedicle. When contact is made,the tip of the neural stimulating component should appear to be on thesuperior lateral wall of the pedicle immediately inferior to the targetdisc.

The surgeon may then use lateral imaging to inspect the location of theneural stimulating component tip. The objective is to place the tip atthe superior edge of pedicle slightly posterior to the pedicle-vertebralbody junction. If it is not at this location, the surgeon may retractthe neural stimulating component, alter the insertion angle, and/orre-advance the neural stimulating component until it is. The surgeon maynext re-orient the C-arm for AP imaging and inspect the neuralstimulating component tip position. If the tip appears at the base ofthe pedicle on the lateral projection and the lateral edge of thepedicle in the AP projection the tip is in the correct location toproceed.

Next, the surgeon may slide the neural monitoring tip superiorly andmedially along the base of the pedicle until it appears to be on thedisc immediately superior to the pedicle, approximately equidistantbetween the medial and lateral margins of the pedicle and near theinferior endplate of the target disc. The exiting nerve root occupiesthe superior most portion of the foramen making placement into the discin a position as inferior as possible desirable for patient safety. Itis not a requirement that the neural stimulating component be centeredon the disc as subsequent dilation instruments will center thesubsequent instruments and gently move the exiting root superiorly asthe space is distracted. During this maneuver, if a neural response isevoked, the surgeon may determine which nerve root has responded. If itis the exiting root the neural monitoring neural stimulating componentis likely too superior or lateral within the foramen, if it is thetraversing root (root exiting at the level below) the placement may betoo medial. Once this response has been determined the neuralstimulating component may be slightly retracted and/or repositionedfarther away from the offended nerve root.

If a location cannot be identified in which a neural response is notevoked at 5 mA or the desired amperage, it may be indicative of a highlycompressed foramen in which the neural elements are filling asignificant portion of the foraminal volume. Should this happen, theamperage may again be turned down slightly (for example, to 4 mA) andthe neural stimulating component may be re-advanced very slowly in orderto determine if a response is evoked. This process of retracting theneural stimulating component and slowly re-advancing may be repeateduntil no response is evoked.

Once a “no response” level is established at the target location theneural stimulating component may once again be withdrawn, but prior tore-advancement the power setting is not altered and the neuralstimulating component is reoriented so that re-advancement will placethe neural stimulating component tip more superiorly in the foramen.Upon readvancement, an evoked response indicates that the power settingis sufficient to penetrate the neural sheath, evoke a response, and thusprovide navigation past the nerve root. After this positive reaction isevoked the surgeon may revert back to the previous trajectory andre-navigate to the level of the disc.

If no response is again seen in this more superior position it is anindication that either the nerve sheath cannot be penetrated with thelow power setting or the nerve root is filling the entire foramen. Ineither instance EMG guidance is not sensitive enough to identify anavigable trajectory past the nerve. In this instance the procedure maybe reattempted from the contralateral side or aborted.

Once the neural stimulating component tip is observed to be on the disc,the energy may be turned to zero and the exchange tube may be slid downthe neural stimulating component shaft to the disc. Slight pressure maybe used to hold the tip against the disc. The neural stimulatingcomponent may then be removed from the exchange tube and may be replacedwith a pointed guide pin.

The surgeon may now revert back to AP imaging and may advance the guidepin until the pin tip is observed to be nearing the lateral margin ofthe canal (medial borders of the pedicles). Then, the surgeon may revertagain to lateral imaging. If the guide pin tip is now seen to beanterior to the posterior margin of the disc, the surgeon may continueto use lateral imaging and may advance the guide pin into the disc untilthe pin tip appears to be at the midpoint. The surgeon may re-orient theC-arm to AP and image. If the trajectory is correct, the guide pin tipwill appear to be in the midline on the AP image. If the trajectory istoo flat (pin tip across midline) or too steep (pin tip not yet tomidline), the guide pin trajectory may be adjusted accordingly. Failureto achieve the correct trajectory may result in container and bone graftplacement that is either anterior and lateral (angle too steep) orposterior and lateral (angle too flat).

Sequential Dilation: Once the correct pin trajectory is determined, theexchange tube may be removed. Using lateral imagery, the surgeon maypass, for example a 4.0 mm, or other desired size, first sequentialdilator over the guide pin, as is depicted in FIG. 3. Imaging may betaken frequently to ensure the guide pin does not advance. An impactioncap may be placed over the end of the guide pin and placed against theback end of the about 4.0 mm sequential dilator. The first sequentialdilator may be impacted approximately 25% of the way across the spine.The guide pin may then be removed.

A second sequential dilator, about 6.5 mm or other desired size, maythen be placed over the first sequential dilator, as is shown in FIG. 4.The second sequential dilator may be advanced toward the spine. Imagingmay be taken frequently to ensure the first sequential dilator does notadvance. An impaction cap may then be placed over the end of the firstsequential dilator and placed against the proximal end of secondsequential dilator. The second sequential dilator may be impacted untilthe distal end of the dilator is approximately 25% of the way across thedisc space. Remove the first sequential dilator. Additional dilators maybe advanced in the same manner as needed.

Instrument Alignment: In an embodiment, a force dissipation andinstrument alignment device, illustrated in FIG. 5, as disclosed inco-pending application Ser. No. 11/655,730, the contents of which areincorporated herein in their entirety, may be used. If such a device isused, the steps may be as follows: the alignment device may be placedover the dilator until the base of the alignment device contacts thepatient. The portal sleeve of the alignment device will extend into theincision. An access portal may then be placed over the dilator andthrough the portal sleeve. The surgeon may use lateral imaging toadvance the access portal until the access portal tip abuts the disc.

An impactor may be placed over the dilator and tapped with a malletuntil the access portal tip advances approximately 5 mm, or the desireddepth into the disc. The dilator may then be removed. As shown in FIG.6, a drill may then be passed through the access portal. The surgeon maybegin drilling and may monitor the progress with lateral imagery. Thedrill may be advanced until contact is made with the positive stop ofthe access portal or the tip of the drill appears to traverseapproximately ¾ of the way across the disc or to the desired depth. Whenthe desired depth is achieved, the final drilling depth can be readimmediately below the positive stop collar on the access portal. Thesurgeon may make note of this depth to assist in selecting a containersize. The drill may then be removed.

Discectomy and Cavity Creation: A shaper, an example of which is shownin FIGS. 7, 8 and 9 may be used to facilitate discectomy anddecortication of the central portion of the disc space. A shaper may bepassed through the access portal until the shaper body contacts theaccess portal positive stop. Shaping may be observed with lateral oroblique imagery to monitor access portal tip location, depth ofinstrument insertion and amount of decortication. The surgeon may thenremove the disc and endplate using the desired tool and method, anexample of which is shown in FIGS. 10, 11 and 12 until the desireddecortication is reached.

To validate that the disc has been removed and appropriate decorticationhas been done a discectomy validation device may be used. As is shown inFIG. 13, the discectomy validation device may be passed through anaccess portal and into the disc space to the distal end of the cavity.The discectomy validation device may then be filled with a contrastsolution or other fluid using low pressure as shown in FIG. 14. Highpressure filling is undesirable as it may result in disc herniation. Aseries of AP, lateral, and oblique images may be taken to evaluate thethoroughness of the disc removal and endplate decortication. If unwanteddisc and endplate material is remaining discectomy validation devicewill outline their location within the disc space. The discectomyvalidation device may then be deflated and removed. If necessary theadditional disc and endplate material may be removed and the disc spacemay be reinspected by placing the discectomy validation device a secondtime. This validation may be repeated as desired.

Container selection and Placement: The surgeon determines theappropriate container size. Such determination may be based on thedrilling depth and the anticipated final disc height. The discectomyevaluation device may also be used to approximate the desired size ofthe container. The surgeon may fill the bladder portion of thediscectomy evaluation device to the desired size and shape and use theamount of solution used to determine the desired container size. Shouldthe surgeon desire to use sentinel graft (i.e., uncontained bone graftused as a post-operative radiographic assessment guide), the surgeon mayplace the sentinel graft, as shown in FIG. 15, directly into the accessportal and use the back end of the dilator to pack the graft into theanterior portion of the disc, or the surgeon may place a full fill tubeinto a sentinel grafting spacer and tamp bone out of the tube with apush rod and mallet.

Once the sentinel graft is placed, the dilator may be advanced throughthe access portal until it contacts the annulus to displace the sentinelgraft to the lateral recesses of the disc space and limit anyinterference the sentinel graft may have with container deployment.

One method of container insertion may include the steps of: assemblingthe container to a container holder by rotating a thumbwheel on thecontainer holder to move a lock tube stop to a proximal position;Aligning an arrow on the container holder with a notch on a metal tip ofthe container and notches in the container holder with a shoulder of themetal tip; Pressing the container into the container holder; Spinning athumbwheel clockwise until a stop abuts with a lock tube; Passing acontainer extender through a cannulation in the container holder;Extending the container; Advancing the container through the accessportal by pressing simultaneously on the container extender and thecontainer holder, as is shown in FIG. 16; Ensuring the container is welldeployed and removing the container holder. Other methods of deployingthe mesh may be used and are within the scope of this disclosure.

Filling the Container: The amount of fill material required to fill acontainer may be determined by the container size and desired finalshape. Fill materials and tools for inserting the fill materialsaccording to some embodiments of the present invention have beendisclosed in the following patents and co-pending patent applicationsU.S. Pat. Nos. 6,620,169, 6,620,162, 7,025,771 and Ser. No. 10/924,240,the disclosures of which are incorporated in the entirety herein. Oncethe container is filled to the desired fill capacity as is shown inFIGS. 17, 18 and 19, the access portal and instrument alignment devicemay be removed and the incisions may be sutured.

The surgeon may then choose to place screws for added support andstabilization as is shown in FIG. 20.

The above-described steps are an example of one method of performing apercutaneous fusion according to the present invention. The steps may becompleted in a different order, some steps may be omitted or other stepsmay be added at the physician's discretion.

What is claimed is:
 1. A method of performing percutaneous interbodyspinal fusion on adjacent vertebrae of a patient, the method comprising:creating a percutaneous access opening into the patient; using indirectvisualization, without retraction, to establish a surgical path to anintervertebral disc through the percutaneous access opening; afterestablishing the surgical path to the intervertebral disc through thepercutaneous access opening, creating a cavity in the intervertebraldisc by inserting an instrument through the surgical path, withoutretraction of the percutaneous access opening; inserting an implantabledevice into the created cavity through the surgical path in anundeployed state, wherein the implantable device in the undeployed stateis sized to fit through the percutaneous access opening withoutretraction of the percutaneous access opening; and after inserting theimplantable device into the cavity, deploying the implantable device. 2.The method of claim 1, further comprising the step of sequentialdilation of the surgical path prior to the step of creating the cavityin the intervertebral disc space.
 3. The method of claim 1, wherein thestep of deploying the implantable device includes expanding theimplantable device sufficiently to distract the adjacent vertebrae. 4.The method of claim 1, wherein all instrumentation for accessing theintervertebral disc space is introduced through the same surgical path.5. The method of claim 1 further including sequentially dilating thesurgical path prior to forming the cavity in the disc, comprising thesteps of: inserting a first dilator through the surgical path, the firstdilator including a tapered tip, wherein the first dilator is inserteduntil the tapered tip penetrates into the vertebral disc to deflectneural structures outward to a major diameter of the first dilator;inserting a second dilator through the surgical path and over the firstdilator, the second dilator having a larger outer diameter than thefirst dilator, the second dilator including having a tapered tipconfigured to further deflect the neural structures outward to a majordiameter of the second dilator.
 6. The method of claim 1, furthercomprising evaluating the cavity created in the intervertebral disc,including inserting a discectomy evaluation device through thepercutaneous surgical path.
 7. A method for performing percutaneousinterbody spinal fusion on adjacent vertebrae of a patient, the methodcomprising: providing imaging equipment adapted to provide indirectvisualization of the patient during the percutaneous interbody spinalfusion procedure and present images of the patient's internal anatomy ona viewing screen visible to a surgeon performing the percutaneousinterbody spinal fusion procedure; forming a percutaneous surgical pathto an intervertebral disc between the adjacent vertebrae; inserting atleast one disc cavity creation tool through the percutaneous surgicalpath; creating the cavity in an intervertebral disc space of theadjacent vertebrae with the at least one disc cavity creation tool;inserting through the percutaneous surgical path an expandable implantin an undeployed state; expanding the collapsed expandable implant whilethe collapsed expandable implant is located within the cavity in theintervertebral disc space; and providing instructions for use of theexpandable implant to perform the percutaneous interbody spinal fusionprocedure.
 8. The method of claim 7, further comprising the step ofinserting sequential dilators through the percutaneous surgical path. 9.The method of claim 7, further comprising providing markings to theimplant for x-ray visualization.
 10. The method of claim 7, furthercomprising sequentially dilating the percutaneous surgical path prior toforming the cavity in the disc, comprising the steps of: inserting afirst dilator through the percutaneous surgical path, the first dilatorincluding a tapered tip, wherein the first dilator is inserted until thetapered tip penetrates into the intervertebral disc to deflect neuralstructures outward to a major diameter of the first dilator; andinserting a second dilator through the percutaneous surgical path andover the first dilator, the second dilator having a larger outerdiameter than the first dilator, the second dilator including a taperedtip configured to further deflect the neural structures outward to amajor diameter of the second dilator.
 11. The method of claim 7, furthercomprising expanding the expandable implant sufficiently to distract theadjacent vertebrae.
 12. The method of claim 7, further comprisingevaluating the cavity created in the intervertebral disc, includinginserting a discectomy evaluation device through the percutaneoussurgical path.
 13. A method of performing percutaneous interbody spinalfusion on adjacent vertebrae of a patient, the method comprising:creating a percutaneous access opening in the patient; establishing apercutaneous surgical path through the percutaneous access opening,without retraction of the percutaneous access opening and withoutdirectly viewing the surgical path, to a vertebral disc of the patientbetween the adjacent vertebrae to be fused; inserting at least one disccavity creation tool through the percutaneous surgical path and creatinga cavity in an intervertebral disc space of the adjacent vertebrae;after the cavity is created in the intervertebral disc space, insertingan expandable device sized and configured to fit through the accessopening, without retraction of the percutaneous surgical path, into thecavity; and expanding the expandable device, after insertion into thecavity.
 14. The method of claim 13, wherein all instrumentation foraccessing the intervertebral disc space is introduced through the samepercutaneous surgical path.
 15. The method of claim 13, wherein theexpandable device is expanded by filling the expandable device with afill material.
 16. The method of claim 13, further comprising the stepof sequential dilation of the percutaneous surgical path prior toforming the cavity in the intervertebral disc space, the sequentialdilation step comprising: inserting a first dilator through thepercutaneous surgical path, the first dilator including a tapered tip,wherein the first dilator is inserted until the tapered tip penetratesinto the vertebral disc to deflect neural structures outward to a majordiameter of the first dilator; and inserting a second dilator throughthe percutaneous surgical path and over the first dilator, the seconddilator having a larger outer diameter than the first dilator, thesecond dilator including having a tapered tip configured to furtherdeflect the neural structures outward to a major diameter of the seconddilator.
 17. The method of claim 13, further including expanding theexpandable device sufficiently to distract the adjacent vertebrae. 18.The method of claim 13, further comprising providing imaging equipmentadapted to provide indirect visualization of the patient during thepercutaneous interbody spinal fusion procedure and present images of thepatient's internal anatomy on a viewing screen visible to a surgeonperforming the percutaneous interbody spinal fusion procedure.
 19. Themethod of claim 13, wherein the step of establishing a surgical paththrough the percutaneous access opening includes using indirectvisualization, without retraction, to place a neural monitoring probeinto the percutaneous access opening to establish the surgical path toan intervertebral disc via neural monitoring.
 20. The method of claim13, further comprising the step of evaluating the cavity created in theintervertebral disc space, including inserting a discectomy evaluationdevice through the percutaneous surgical path.